Pilot Study Evaluating Epinamel Device for Treating Dental White Spot Lesions After Braces Removal

What this Trial Is About

Researchers are evaluating the Epinamel device developed by Mintech-Bio Ltd to treat dental white spot lesions, which are early signs of tooth enamel loss often caused by decay or erosion. These lesions affect many people worldwide and may be linked to other health problems like diabetes and heart issues. The study aims to show how well Epinamel works to repair enamel after braces removal by comparing it to an existing product called Curodont Repair. The treatment involves applying the Epinamel gel, a two-part professional dental device that promotes enamel repair by trapping calcium and phosphate from saliva to grow natural hydroxyapatite mineral. Participants will have Epinamel applied to teeth on one side of their mouth, while the control product is applied to the opposite side. This application occurs after the removal of dental braces or brackets. Participants will be monitored over a 6-week period to assess changes in the size of white spot lesions using morphometry and laser fluorescence readings. The study includes regular visits for treatment application and evaluation. Researchers will measure the improvement or progression of lesions and collect objective fluorescence data to evaluate lesion status, ensuring participant oral hygiene and safety throughout the study.

Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions